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NCT05387707 · ClinicalTrials.gov registry record · Phase 3

Study to Evaluate the Efficacy and Safety of Oral Difelikefalin as Adjunct Therapy to a Topical Corticosteroid for Moderate to Severe Pruritus in Subjects With Atopic Dermatitis

A Phase 3 study, sponsored by Cara Therapeutics.

Terminated
Registry status
Phase 3
Development phase
287
Enrollment target

NCT05387707 is a Phase 3 study that was terminated before completion, run by Cara Therapeutics. The registered enrollment target is 287 participants.

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The verdict

NCT05387707, a Phase 3 study, was terminated before completion, sponsored by Cara Therapeutics.

TERMINATED
Registry status
Phase 3
Development phase
287 participants
Enrollment target

Study Summary

This is a two-part, multicenter, randomized, double-blind study to evaluate the efficacy and safety of oral difelikefalin as adjunct therapy to a topical corticosteroid (TCS) for moderate-to-severe pruritus in adult subjects with atopic dermatitis (AD).

Interventions

  • DRUG Placebo
  • DRUG Vehicle Cream
  • DRUG TCS Cream
  • DRUG difelikefalin 0.25 mg
  • DRUG difelikefalin 0.5 mg

Trial Details

FieldValue
Enrollment Target 287 participants
Start Date 2022-08-16
Est. Completion 2024-02-02
Phase Phase 3

Sponsor

Cara Therapeutics

23 total trials

What the Registry Record Tells You About NCT05387707

The ClinicalTrials.gov registry entry for NCT05387707 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 287 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Cara Therapeutics, which has 23 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 5 interventions - of which Placebo is the first listed.

NCT05387707 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT05387707 about?

NCT05387707 is a clinical study titled "Study to Evaluate the Efficacy and Safety of Oral Difelikefalin as Adjunct Therapy to a Topical Corticosteroid for Moderate to Severe Pruritus in Subjects With Atopic Dermatitis". This is a two-part, multicenter, randomized, double-blind study to evaluate the efficacy and safety of oral difelikefalin as adjunct therapy to a topical corticosteroid (TCS) for moderate-to-severe pruritus in adult subjects with atopic dermatitis (AD).

What is the current status of trial NCT05387707?

This trial is currently terminated. It is a Phase 3 study. The enrollment target is 287 participants. The study started on 2022-08-16. Estimated completion is 2024-02-02.

What interventions are being tested in trial NCT05387707?

The interventions under investigation include: Placebo (DRUG), Vehicle Cream (DRUG), TCS Cream (DRUG), difelikefalin 0.25 mg (DRUG), difelikefalin 0.5 mg (DRUG).

Who is sponsoring clinical trial NCT05387707?

This trial is sponsored by Cara Therapeutics, which has 23 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.